Identity
- Trade Name
- CLEANER SAMPLE PACK (Bright Shield/VacAttak) EUDAMEDBrite Shield FDA UDI
- Generic Name
- Medical device disinfection agent FDA UDI
- Device Name
- Brite Shield/Vac Attak Sample EUDAMEDCLEANER SAMPLE PACK (BS/VA) FDA UDI
- Model / Reference
- 9011950 EUDAMEDFDA UDI
- Description
- CLEANER SAMPLE PACK (BS/VA) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00348783003819 EUDAMEDFDA UDI
- Basic UDI-DI
- 00348783BS/VASampleXN EUDAMED
- FDA Product Code
- FLG FDA UDI
- EMDN Code
- D0801 ENZYMATIC DETERGENTS FOR MEDICAL DEVICES EUDAMED
- GMDN Term
- Medical device disinfection agent FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6150 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical device disinfection agent
Brite Shield by Premier Dental Products Company — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Medical device disinfection agent.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Premier Dental Products Company
Sources (2)
- FDA UDI 85ecd712-20c3-4fc7-aac9-0950a3fa5e60 33 fields · synced Jun 19, 2026
- EUDAMED b1791390-7497-46cb-a3dc-d78e21270cef 61 fields · synced Jun 19, 2026